关键词: 肌钙蛋白I, 心肌梗死, 敏感性与特异性, ROC曲线

Abstract: [abstract] objective To evaluate the analytical performance of ADVIA Centaur TnI-Ultra testing method, in order to help the clinical diagnosis of AMI . Methods To collect the serum of emergency department patients with chest pain immediately and detect TnI-Ultra. consult 2000 ESC/ACC for AMI diagnostic criteria to diagnos AMI. Calculate the positive rate of immediated detection of patients. according to ROC curves of TnI-Ultra test results in the diagnosis of characteristics with AMI for evaluation. Evaluation of this method function sensitivity (CV = 10%), within- and between run imprecision. Results confirmed immediated positive rate of AMI patients was 34.2%, the area under the ROC curves was 0.956, definite diagnosis threshold value was 0.436 ng/ml, at this threshold value sensitivity was 90.2%, specificity was 87.3%. TnI-Ultra function sensitivity when CV=10% was 0.042 ng/ml, when CV=20% was 0.0195 ng/ml. Low concentration serum (nearly 0.04 ng/ml) within-run CV was 7.9%, between run CV was 8.1%; High concentration serum (0.11 ng/ml) within-run CV was 4.6 %, between run CV was 5.4%. Conclusion ADVIA Centaur TnI-Ultra detection method analysis performance reach "guideline acceptable" (CV=10% or less), but when AMI happened, judgment threshold the provided materials by manufacturers have difference, the application of routine clinical diagnosis still needs further observation and study.